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Could a pill cut falls in Parkinson's? new trial investigates

NCT ID NCT05258071

Symptom relief Sponsor: Integrative Research Laboratories AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether a drug called pirepemat can reduce how often people with Parkinson's disease fall. Participants take the drug or a placebo for 84 days and record falls in a diary. The study includes people aged 55–85 who have had at least two falls in the past month. If it works, pirepemat could offer a new way to manage a common and dangerous symptom of Parkinson's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pirepemat (also called IRL752)
What this could lead to
If successful, pirepemat could become a new treatment to reduce falls in people with Parkinson's disease, improving safety and quality of life.
What could go wrong
This is an early-phase trial with only 104 participants. The drug may not reduce falls more than a placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

104 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female 55-85 years of age, inclusive. 2. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria. 3. Montreal Cognitive Assessment (MoCA) score of ≥10 and \<26 at screening. 4. A modified Hoehn \& Yahr score of ≥2.5 in "on". 5. Having experienced recurrent falls during the past 3 months (based on interview with the patient and/or caregiver) and at least 2 falls during the past 4 weeks before baseline. 6. On a stable regimen of anti-Parkinson's medications for at least 30 days prior to baseline, and willing to continue the same doses and regimens during study participation. 7. Able to cooperate and participate in study related procedures. This includes the ability to accurately complete a fall diary. The fall diary may also be completed by a responsible caregiver. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, the fall diary should be completed by the caregiver. 8. Availability of a responsible caregiver at least five days per week at least 2 hours per day. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, availability of a responsible live-in caregiver is required. 9. Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and oestradiol \<200 pmol/L is confirmatory\]). 10. Fertile male patients must be willing to use condom and refrain from donating sperm during the study and until 3 months after last dosing of IMP and ensure that their fertile female partners are using contraceptive methods to prevent pregnancy . 11. Written informed consent for participation in the study given by the patient and the responsible caregiver. Exclusion Criteria: 1. Any of the following potential hepatic conditions: 1. known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert's syndrome 2. total bilirubin greater than the upper limit of the normal range (unless associated with isolated instances of suspected Gilbert's syndrome) 3. alkaline phosphatase (ALP) greater than 1.5 times the upper limit of the normal range 4. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of the normal range 5. history of repeated unexplained upper right quadrant abdominal pain and/or nausea, or jaundice 2. A positive Hepatitis B surface antigen or a positive Hepatitis C antibody result. 3. A score of 5 (wheelchair bound or bedridden) in the "on"-state on the modified Hoehn \& Yahr scale. 4. Uncontrolled symptomatic orthostatic hypotension. 5. Clinically significant polyneuropathy. 6. Weight \<55 kg at Screening. 7. Patients with current or past treatment with deep brain stimulation (DBS) or patients with previous history of stereotaxic brain surgery for PD. 8. A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD. 9. A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia. 10. A current diagnosis of a major depressive episode according to DSM-IV criteria. 11. Patient has delirium. 12. Any history of a heart condition, including prolonged QTc (\>450 ms for males and \> 470 ms for females, QTcF and/or QTcB), cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator. 13. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; renal failure, history of abnormal renal function. 14. History of seizures within two years of screening. 15. History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer. 16. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to pirepemat. 17. Creatinine clearance \<30 mL/min (calculated according to the Cockroft-Gault formula). 18. Treatment with Warfarin within three months before study treatment. 19. Treatment with Amantadine within 6 weeks before study treatment. 20. Treatment with Selegiline within 6 weeks before study treatment. 21. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. 22. Current or history of drugs of abuse according to DSM-IV criteria. 23. Any planned major surgery within the duration of the study. 24. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgement.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • CHU Charles Nicolle

    Rouen, France

  • CHU Toulouse - Hôpital Purpan

    Toulouse, France

  • Centrum Medyczne HCP SP Z OO

    Poznan, Poland

  • Centrum Medyczne NeuroProtect

    Warsaw, Poland

  • Charite Universitatsmedizin Berlin - Klinik fuer neurologie mit experimenteller neurologie

    Berlin, Germany

  • Clinica Universitaria de Navarra

    Pamplona, Spain

  • Diamond Clinic sp. z o.o.

    Krakow, Poland

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, Poland

  • Hopital de la Timone

    Marseille, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital General Universitario de Elche

    Elche, Spain

  • Hospital Infanta Sofia

    Madrid, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario del Henares

    Madrid, Spain

  • Hospital de Sant Pau

    Barcelona, Spain

  • Hôpital Laennec - Centre d'investigation clinique de Neurologie

    Nantes, France

  • Hôpital Neurologique Pierre Wertheimer

    Bron, France

  • Institute of Neuroscience and Physiology

    Gothenburg, Sweden

  • Instytut Zdrowia

    Oświęcim, Poland

  • Karolinska Universitetssjukhuset - Neurologiska kliniken

    Stockholm, Sweden

  • Kliniken Kreis Muehldorf a. Inn

    Mühldorf, Germany

  • Klinische Forschung Hamburg GmbH

    Hamburg, Germany

  • Klinische Forschung Schwerin GmbH

    Schwerin, Germany

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow, Poland

  • Neuro-Care Clinic

    Siemianowice Śląskie, Poland

  • Philipps-Universitaet Marburg

    Marburg, Germany

  • Pratia MCM Krakow

    Krakow, Poland

  • Praxis Dr.med. Christian Oehlwein Facharzt für Neurologie und Psychiatrie

    Gera, Germany

  • RCMed

    Sochaczew, Poland

  • RKU - Universitäts- und Rehabilitationskliniken Ulm Klinik für Neurologie

    Ulm, Germany

  • Radboud Universitair Medisch Centrum (Radboudumc)

    Nijmegen, Netherlands

  • Silmedic sp. z o.o

    Katowice, Poland

  • Singua Sp. z o.o.

    Warsaw, Poland

  • Skane University Hospital - Division of Neurology

    Lund, Sweden

  • Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Neurologie

    Leipzig, Germany

  • Universitysklinikum Münster - Klinik für neuroligie

    Münster, Germany

  • Universitätsmedizin Göttingen - Klinik für Neurologie

    Göttingen, Germany

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